MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00539250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned flexima biliary stent was analyzed, and a visual evaluation noted that the guide catheter was removed and it was observed detached, stretched, and kinked in several sections.The push catheter was observed kinked in the proximal section and the push catheter suture hole was observed torn.The stent and suture were not returned for analysis.No other issues with the device were noted.The reported event was confirmed.According to product analysis, it is most likely that procedural or anatomical factors encountered during the procedure or preparation could have affected the device performance and its integrity.The patient anatomy and customer maneuvering during the use of the device or preparation can lead to the observed kinks in the device.The kinks in the device could have generated resistance to retract the pull wire and guide catheter, continued attempts or forced to retract the guide catheter to release the stent can result in a guide catheter breaking generating the found guide catheter detachment and stretched issue.Additionally, the suture under tensile force during the procedure due to the kink/bent section could result in the tearing of the suture hole, generating the reported problem.Therefore, adverse event related to procedure is selected as the most probable root cause for the compaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2021.During preparation, when physician attempted to release the suture, it was noted that the suture was broken.Another flexima biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation finding of guide catheter broken.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11999062
• Report Number: 3005099803-2021-02815
• Device Sequence Number: 1099019
• Product Code: FGE
• UDI-Device Identifier: 08714729162568
• UDI-Public: 08714729162568
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: M00539250
• Device Catalogue Number: 3925
• Device Lot Number: 0025081864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 70